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| ID | Type | Description | Link |
|---|---|---|---|
| P50CA244433 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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This work is an implementation science study that examines different aspects of implementing a single intervention. The intervention consists of asking community health centers to implement an outreach strategy to screen patients for colorectal cancer and for social determinants of health in community health centers at the same contact point. These are both clinical targets that the CHCs feel that their patients need and want to offer at a higher rate. The intervention consists of outreach to patients in need of colorectal cancer screening (CRC) to offer fecal immunochemical test (FIT) screening and screening for social determinants of health (SDOH). In this implementation science study, the intervention is an evidence-based intervention being implemented in real-world clinical practice. The intervention is the outreach to offer FIT and SDOH, conducted by clinic staff. Both evidence-based screening activities-FIT and SDOH screening-are used in the practices included in the study but pairing them is intended to increase efficiency and patient-centeredness by addressing health related social needs that may impact patients' ability to engage in cancer screening. The study aims to test the effect of implementing the intervention on clinical and process outcomes. Clinical outcomes are CRC screening and SDOH screening. Analysis of process outcomes includes measuring what organizational factors influence implementation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paired Screening Intervention | Experimental |
| |
| Usual Care Control | No Intervention | In this stepped wedge design, all sites have a period of being in usual care, and then providing the Paired Screening Intervention. Sites serve as their own controls in this design. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paired Screening Intervention | Behavioral | The intervention is the implementation of a paired outreach strategy to patients in need of colorectal cancer screening to offer FIT testing and to complete screening for social determinants of health. These screening activities are part of routine practice but the intervention that is being implemented is the paired outreach for both CRC screening and SDOH screening. |
| Measure | Description | Time Frame |
|---|---|---|
| Conditional Odds Ratio of Patients Screened for Colorectal Cancer During Intervention Compared to Patients Screened During Usual Care | Colorectal cancer screening completion by any guideline-based method. Adjusting for patient socio-demographics, comorbidities, number of healthcare visits, and secular trend. Documented screening in EHR for patients unscreened at the beginning of the step. | 13 pre implementation months, 14 post-implementation months |
| Conditional Odds Ratio of Patients Screened for Social Needs During Intervention Compared to Patients Screened During Usual Care | Completion of social needs screening (collected as part of routine clinical care). Adjusting for patient socio-demographics, comorbidities, number of healthcare visits, and secular trend. Documented screening in EHR for patients unscreened at the beginning of the step. | 13 pre implementation months, 14 post-implementation months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of FIT Kits Mailed | Adoption measured by number of FIT kits mailed to patients. Data were summed to calculate a single value. | 4 months post-implementation, 8 months post-implementation |
| Number of Reminders Per FIT Mailing |
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Study participants include community health center staff participating in interviews about the implementation of the intervention. Up to four community health center staff members at each of the four community health centers will participate in key informant interviews twice per year. Patients will receive the paired screening intervention as part of their routine care and will not be individually recruited for the study because the intervention is being offered as part of routine care.
Staff Participants
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Emmons, PhD | Harvard TH Chan School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harbor Health Services | Boston | Massachusetts | 02122 | United States | ||
| Brockton Neighborhood Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38332440 | Derived | Kruse GR, Percac-Lima S, Barber-Dubois M, Davies ME, Gundersen DA, Ho O, Mascioli L, Munshi M, Perry S, Singh D, Thomas A, Emmons KM, Haas JS. Bundling Colorectal Cancer Screening Outreach with Screening for Social Risk in Federally Qualified Health Centers: A Stepped-Wedge Implementation-Effectiveness Study. J Gen Intern Med. 2024 May;39(7):1188-1195. doi: 10.1007/s11606-024-08654-5. Epub 2024 Feb 8. | |
| 36194312 | Derived | Aschbrenner KA, Kruse G, Emmons KM, Singh D, Barber-Dubois ME, Miller AM, Thomas AN, Bartels SJ. Stakeholder and Equity Data-Driven Implementation: a Mixed Methods Pilot Feasibility Study. Prev Sci. 2024 Apr;25(Suppl 1):136-146. doi: 10.1007/s11121-022-01442-9. Epub 2022 Oct 4. |
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Individual participant data that underlie the results reported here, after deidentification (text, tables, figures, and appendices). Upon request and appropriate approvals.
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6 months after publication, and for 3 years.
Outside investigators will need an approved concept proposal to analyze study data and spend the requisite time with study staff to learn about the data elements needed to conduct the proposed analysis. With the assistance of our analytic team, s/he will draft a detailed analysis plan and present to the core group of co-investigators. The discussion at this meeting ensures adequate knowledge of the data, and the presenter gains much insight into how the analysis can be most useful and how it relates to previous analyses. Once the plan is approved by this group, it must also be approved by the CHCs that provide the de-identified data. Following approval by the appropriate IRBs and confirmation that it meets HIPAA requirements, s/he may sign a DUA to use a secure, de-identified dataset to complete only the approved analyses and write the manuscript(s) offsite. A formal data analysis plan application and DUA are still in development. Requests should be directed to jdaly@hsph.harvard.edu.
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Community health center staff are only considered enrolled.
Study participants include community health center staff participating in interviews about the implementation of the intervention. Patients received the paired screening intervention as part of their routine care and were not individually recruited for the study because the intervention was offered as part of routine care.
| ID | Title | Description |
|---|---|---|
| FG000 | Sequence A | 8 months usual care, then 4 months paired outreach followed by 10 months planned adaptation. Paired Screening Intervention: The intervention is the implementation of a paired outreach strategy to patients in need of colorectal cancer screening to offer FIT testing and to complete screening for social determinants of health. These screening activities are part of routine practice but the intervention that is being implemented is the paired outreach for both CRC screening and SDOH screening. In this stepped wedge design, all sites have a period of being in usual care, and then providing the Paired Screening Intervention. Sites serve as their own controls in this design. |
| FG001 | Sequence B | 10 months Usual care, then 4 months paired outreach, followed by 8 months planned adaptation. Paired Screening Intervention: The intervention is the implementation of a paired outreach strategy to patients in need of colorectal cancer screening to offer FIT testing and to complete screening for social determinants of health. These screening activities are part of routine practice but the intervention that is being implemented is the paired outreach for both CRC screening and SDOH screening. In this stepped wedge design, all sites have a period of being in usual care, and then providing the Paired Screening Intervention. Sites serve as their own controls in this design. |
| FG002 | Sequence C | 12 months usual care, then 4 months paired outreach followed by 6 months planned adaptation. Paired Screening Intervention: The intervention is the implementation of a paired outreach strategy to patients in need of colorectal cancer screening to offer FIT testing and to complete screening for social determinants of health. These screening activities are part of routine practice but the intervention that is being implemented is the paired outreach for both CRC screening and SDOH screening. In this stepped wedge design, all sites have a period of being in usual care, and then providing the Paired Screening Intervention. Sites serve as their own controls in this design. |
| FG003 | Sequence D | 14 months Usual care, then 4 months paired outreach followed by 4 months planned adaptation. Paired Screening Intervention: The intervention is the implementation of a paired outreach strategy to patients in need of colorectal cancer screening to offer FIT testing and to complete screening for social determinants of health. These screening activities are part of routine practice but the intervention that is being implemented is the paired outreach for both CRC screening and SDOH screening. In this stepped wedge design, all sites have a period of being in usual care, and then providing the Paired Screening Intervention. Sites serve as their own controls in this design. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Usual Care |
| ||||||||||||||||
| Paired Outreach |
|
Demographic data were not collected from participants (i.e., community health center staff) described in Participant Flow. Patients received the paired screening intervention as part of their routine care and were not individually recruited for the study because the intervention is being offered as part of routine care. Baseline characteristics and outcomes reported are based on the patient-level data.
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| ID | Title | Description |
|---|---|---|
| BG000 | Paired Screening Intervention | Paired Screening Intervention: The intervention is the implementation of a paired outreach strategy to patients in need of colorectal cancer screening to offer FIT testing and to complete screening for social determinants of health. These screening activities are part of routine practice but the intervention that is being implemented is the paired outreach for both CRC screening and SDOH screening. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | unique patient count in each arm |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Conditional Odds Ratio of Patients Screened for Colorectal Cancer During Intervention Compared to Patients Screened During Usual Care | Colorectal cancer screening completion by any guideline-based method. Adjusting for patient socio-demographics, comorbidities, number of healthcare visits, and secular trend. Documented screening in EHR for patients unscreened at the beginning of the step. | 4 Community health centers were randomized to a sequence of implementation start and each observed for an average of 2.5 control periods (stepped wedge steps) and 5.5 intervention periods (stepped wedge steps). | Posted | Number | Conditional odds | 13 pre implementation months, 14 post-implementation months | health centers | health centers |
|
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Patients received the paired screening intervention as part of their routine care and were not individually recruited for the study because the intervention was offered as part of routine care. Enrolled study participants were community health center staff participating in interviews about the implementation of the intervention. Therefore adverse event reporting did not apply.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Paired Screening Intervention | Paired Screening Intervention: The intervention is the implementation of a paired outreach strategy to patients in need of colorectal cancer screening to offer FIT testing and to complete screening for social determinants of health. These screening activities are part of routine practice but the intervention that is being implemented is the paired outreach for both CRC screening and SDOH screening. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Daly | Harvard TH Chan School of Public Health | 617-384-8915 | jdaly@hsph.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 9, 2021 | Apr 4, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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This trial uses a randomized stepped wedge study design. This pragmatic design involves a sequential, randomized roll-out of the intervention across the four participating clinical sites or "clusters" over 8 week intervals or "steps." The intervention is the paired outreach to patients in need of CRC screening to offer FIT screening and screening for SDOH. The participants who will be enrolled are CHC staff who will provide input on the implementation processes and outcomes.
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|
Adoption measured by number of reminders per FIT mailing to patients. Data were summed to calculate a single value.
| 4 months post-implementation, 8 months post-implementation |
| Number of Reminders Per FIT Return | Adoption measured by number of reminders per FIT returned. Data were summed to calculate a single value. | 4 months post-implementation, 8 months post-implementation |
| Brockton |
| Massachusetts |
| 02301 |
| United States |
| Lowell Community Health Center | Lowell | Massachusetts | 01854 | United States |
| Manet Community Health Center | Quincy | Massachusetts | 02171 | United States |
| Number of Patients | Patients are not enrolled |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Usual Care Control | In this stepped wedge design, all sites have a period of being in usual care, and then providing the Paired Screening Intervention. Sites serve as their own controls in this design. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Usual Care Control | In this stepped wedge design, all sites have a period of being in usual care, and then providing the Paired Screening Intervention. Sites serve as their own controls in this design. |
|
|
|
| Primary | Conditional Odds Ratio of Patients Screened for Social Needs During Intervention Compared to Patients Screened During Usual Care | Completion of social needs screening (collected as part of routine clinical care). Adjusting for patient socio-demographics, comorbidities, number of healthcare visits, and secular trend. Documented screening in EHR for patients unscreened at the beginning of the step. | 4 Community health centers were randomized to a sequence of implementation start and each observed for an average of 2.5 control periods (stepped wedge steps) and 5.5 intervention periods (stepped wedge steps). | Posted | Number | Conditional odds | 13 pre implementation months, 14 post-implementation months | health centers | health centers |
|
|
|
|
| Secondary | Number of FIT Kits Mailed | Adoption measured by number of FIT kits mailed to patients. Data were summed to calculate a single value. | Posted | Number | FIT kits | 4 months post-implementation, 8 months post-implementation | health centers | health centers |
|
|
|
| Secondary | Number of Reminders Per FIT Mailing | Adoption measured by number of reminders per FIT mailing to patients. Data were summed to calculate a single value. | unique patients within the 4 months post-implementation, 8 months post-implementation | Posted | Number | reminders per mailed FIT kits | 4 months post-implementation, 8 months post-implementation | health centers | health centers |
|
|
|
| Secondary | Number of Reminders Per FIT Return | Adoption measured by number of reminders per FIT returned. Data were summed to calculate a single value. | Posted | Number | reminders per returned FIT kit | 4 months post-implementation, 8 months post-implementation | health centers | health centers |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Usual Care Control | In this stepped wedge design, all sites have a period of being in usual care, and then providing the Paired Screening Intervention. Sites serve as their own controls in this design. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |